Hims & Hers
Healthcare
VP,RegulatedDeviceEngineering
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“VP, Regulated Device Engineering at Hims & Hers. Skills: Regulated device engineering, Product development, Regulatory compliance. Define strategic roadmap. Execute strategic roadmap”
What You'll Achieve.
Successful product development; Successful approval; Successful market adoption; Inspection readiness; Successful audits; Scalable production; Cost-effective production; Compliant production; Continuous improvement; Reduced time-to-market; Reduced cost efficiency
Industry & Context.
Risk management; Usability engineering
What They're Looking For.
Must Have
Bachelor's degree in Mechanical Engineering, 15+ years of experience in medical device industry, Significant experience in Class II devices, Proven leadership experience overseeing R&D teams, Proven leadership experience overseeing product development pipelines, Deep knowledge of FDA regulations, Knowledge of 21 CFR Part 820, Knowledge of ISO 13485, Knowledge of ISO 14971, Demonstrated success leading products through regulatory clearance, Demonstrated success leading products through commercialization, Experience working closely with Quality and Regulatory functions, Experience in a design controlled environment
What You'll Do.
Define strategic roadmap
Execute strategic roadmap
Own resource allocation
Partner to identify new product opportunities
Build high-performing organization
Scale high-performing organization
Lead R&D developing medical devices
Ensure design control processes are robust
Ensure design control processes are compliant
Ensure design control processes are efficiently executed
Maintain disciplined product development processes
Ensure products meet FDA requirements
Ensure products meet international regulatory requirements
Ensure products meet quality system requirements
Partner with Quality leaders
Partner with Regulatory leaders
Support successful submissions
Champion culture of quality
Champion culture of compliance
Ensure inspection readiness
Ensure successful audits
Provide indirect leadership
Provide alignment across Clinical
Provide alignment across Manufacturing
Provide alignment across Supply Chain
Ensure clinical strategies support objectives
Collaborate with Manufacturing
Collaborate with Operations
Ensure scalable production processes
Ensure cost-effective production processes
Ensure compliant production processes
Drive continuous improvement
Identify technical risks
Mitigate technical risks
Identify regulatory risks
Mitigate regulatory risks
Identify operational risks
Mitigate operational risks
How You'll Work.
Team & Collaboration
Cross-functional influence; Quality and Regulatory leaders; Clinical, Manufacturing, Supply Chain
Process & Methodology
Product development pipelines
Full Job Description
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about http://hims.com/about and hims.com/how-it-works http://hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals http://www.hims.com/careers-professionals. ABOUT THE ROLE: The VP, Regulated Device Engineering is responsible for the overall leadership, strategy, and execution of the company’s regulated medical device business organization. This role owns end-to-end product development, from concept through commercialization, ensuring compliance with all FDA and global regulatory requirements while driving innovation, quality, and operational excellence. This leader will directly oversee Research & Development and have cross-functional influence with Quality, Regulatory Affairs, Clinical, and Manufacturing to ensure successful product development, approval, and market adoption. BUSINESS & STRATEGIC LEADERSHIP - Define and execute the strategic roadmap for the regulated devices portfolio, aligned with company growth objectives - Own budgeting, and resource allocation for the regulated devices business unit • Partner with executive leadership to identify new product opportunities • Build and scale a high-performing, cross-functional organization Product
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